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| Name | Class |
|---|---|
| Rehabilitation Center Rødovre Municipality (Genoptræning Rødovre Kommune) | UNKNOWN |
| Den Kommunale Kvalitetsudviklingspulje | UNKNOWN |
| Lundbeckpuljen | UNKNOWN |
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Background: The number of people living with chronic conditions limiting the ability to perform activities of daily living (ADL) tasks is increasing. Occupational therapists are trained to deliver interventions to improve ADL ability. Municipality occupational therapy interventions are usually delivered as one-to-one sessions in the client´s home. While this intervention format might be effective, a group-based intervention format might be as effective but more cost-effective? Hence, the group-based ADAPT program was developed, piloted and evaluated for its functioning and feasibility in municipality settings. These studies provided initial evidence for the ADAPT Programs effectiveness. A randomized controlled trial (RCT) is however needed to document effectiveness, processes, and cost-effectiveness of the ADAPT program versus usual occupational therapy (UOT) for people with chronic conditions. Prior to the RCT, this pilot and feasibility study will be conducted to test aspects of trial design, conduct and processes as well as intervention content and delivery.
Material and Methods: A total of 16 home dwelling persons with chronic conditions, experiencing ADL task performance problems will be randomized and allocated to receive ADAPT (intervention) or UOT (control). Effectiveness and cost-effectiveness assessments are collected at baseline and post intervention i.e., 3-months (week 12) and 6-months (week 26) from baseline. Pilot and feasibility aspects will be evaluated by means of registrations forms filled out by the OTs delivering ADAPT and people with chronic conditions attending ADAPT. Registrations are designed to inform aspects of 1) recruitment and retention, 2) trial participation, 3) impact of trial on participants and staff, 4) completion rates, 5) fidelity and dose 6) assesable information and 7) adaptation of trial conduct to local context. Progression criteria for when to 'go', 'amend' or 'be alert/stop' are defined, to support the decision on whether to continue to RCT or the need to adjust design or procedures,
TThe specific aims of this pilot and feasibility study are to evaluate:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADAPT program | Experimental | The ADAPT program is a structured and individualized group-based program. |
|
| Usual Occupational Therapy (UOT) | Active Comparator | UOT is delivered by one occupational therapist. . |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADAPT program | Other | The ADAPT program is a structured and individualized group-based program, in which two occupational therapists teach groups of people the skills of problem-solving more efficiently as means to overcome ADL task performance problems. The ADAPT program 3.0 includes 10 two-hour sessions and is followed by two booster sessions to support sustainable gains. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in observed motor ability | Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome | week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in self-reported ability to perform activities of daily living tasks | ADL-Interview (ADL-I, Performance) is a unidimensional linear measure in which higher scores are better outcome | week 12 and 26 |
| Change in observed motor ability |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived mental well-being | WHO-5 questionnaire based on a 6-point ordinal scale in which higher is better outcome | week 12 and 24 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cecilie von Bülow, PhD | Parker Institute, Bispebjerg and Frederiksberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Parker Research Institute, Department of Rheumatology, Copenhagen University Hospital, Bispebjerg and Frederiksberg Frederiksberg, Denmark | Frederiksberg | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42249425 | Derived | von Bulow C, Bojesen SB, Hagelskjaer V, Nielsen KT, Waehrens EE. Group-based versus one-to-one occupational therapy to improve ADL ability in people with chronic conditions: a pilot and feasibility RCT of the Go:OT study. Pilot Feasibility Stud. 2026 Jun 6. doi: 10.1186/s40814-026-01855-1. Online ahead of print. |
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| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Oak Foundation |
| OTHER |
| Tværspuljen | UNKNOWN |
A randomized controlled pilot and feasibility study
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The trial attempts to blind clients and assessors. Clients are informed that they will be allocated to one of two occupational therapy intervention programs that both aims to improve ADL ability, but overall primarily differ in the format i.e. a group-based versus a one-to-one intervention program. Clients are however not informed, which of the two types of formats that are the new experimental intervention format (ADAPT). Baseline assessments are conducted prior to randomization by the local project coordinator and the project coordinator is instructed not to reveal which intervention that is the new experimental intervention. The post- and follow-up assessor, an externally recruited occupationa therapist from a nearby hospital research unit, is also instructed not to disclose which intervention that is the new. Finally, all clients are reminded not to disclose any details, that may provide the outcome assessor with insight regarding their group allocation.
|
| UOT | Other | UOT is delivered by one occupational therapist. Sessions are individualised and focus on improving ADL ability e.g. by practicing the performance of ADL task. UOT typiccally includes 7 one-to-one sessions of 60 minutes, delivered over a 10-week period in the clients´ homes. The dose is however not fixed but based on the occupational therapists´ clinical judgement. |
|
Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome
| week 26 |
| Change in observed process ability | Assessment of Motor and Process Skills (AMPS) is a unidimensional linear measure in which higher scores are better outcome | week 12 and 26 |
| Change in self-reported satisfaction with ability to perform activities of daily living tasks- | ADL-Interview (ADL-I Satisfaction) | week 12 and 26 |
| Perceived change in ability to perform activities of daily living tasks | Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables | week 12 and 26 |
| Perceived change in occupational balance | Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables | week 12 and 26 |
| Perceived change ability to problemsolve | Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables | week 12 and 26 |
| Perceived change in need for assistance | Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables | week 12 and 26 |
| Perceived change in Quality fo life | Transition Questionnaire (TRANS-Q) based on a scale of seven categorical variables | week 12 and 26 |
| Perceived Quality of life | EuroQoL 5 dimensions (EQ-5D) based on a scale of five categorical variables | week 12 and 26 |
| Perceived generel health | First questions in the MOS 36-item Short Form Survey Instrument based on a scale with 5 categorical variables | week 12 and 26 |